ClinicalTrials.gg
Not yet recruitingNCT07759661IMPACTUpdated Aug 13, 2026

Innovative 3D Preclinical Models for Mature B-cell Malignancies to Advance Personalized Immuno and Combination Therapies

An observational study in Chronic Lymphocytic Leukemia (CLL), Splenic Marginal Zone Lymphoma and Hairy Cell Leukemia (HCL), sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by IRCCS San Raffaele · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
64
Ages
18 Years and older
Sex
All
01

Study summary

Adult patients with chronic lymphocytic leukemia (CLL), splenic marginal-zone lymphoma (SMZL) and hairy cell leukemia (HCL) followed at participating clinical sites will be enrolled and undergo sampling of additional amount of blood during the blood draws performed as part of standard clinical care.

The project aims to develop and validate innovative patient-derived 3D bioprinted models that faithfully reproduce the key microenvironments of lymphoid tissues, enabling a more physiologically relevant study of mature B-cell malignancies.

02

Conditions studied

  • Chronic Lymphocytic Leukemia (CLL)
  • Splenic Marginal Zone Lymphoma
  • Hairy Cell Leukemia (HCL)

Keywords

  • B-cell malignancies
  • 3D models
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

This study's planned enrollment of 64 is below the median of 146 across 215 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with CLL, SMZL, HCL followed at participating clinical sites

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Diagnosis of CLL, SMZL or HCL
  • Participant is willing and able to autonomously give for participation in the study.

Exclusion criteria

Exclusion Criteria:

- Participant is unable or unwilling to provide for participation in the study

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
64 participants (estimated)
Patient registry
No

Groups and cohorts

  • CLL

    Patients diagnosed with CLL

  • SMZL

    Patients diagnosed with SMZL

  • HCL

    Patients diagnosed with HCL

06

What researchers measure

Primary outcomes

  1. To generate 3D culture models from patients with CLL, SMZL, HCL

    ≥50% 3D culture models generated from patients with CLL, SMZL and HCL, defined as cell viability \>80% per sample in standard condition

    Time frame: 36 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07759661
Lead sponsor
IRCCS San Raffaele
Collaborators
Ministry of Health, Italy
Responsible party
Cristina Scielzo (Head, Malignant B cells biology and 3D modelling Unit, IRCCS San Raffaele) — Principal investigator
First posted
Aug 12, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Aug 13, 2026

Study contacts

Cristina Scielzo, PhD
Contact
scielzo.cristina@hsr.it
+390226436487
Lydia Scarfò, MD
Contact
scarfo.lydia@hsr.it
+390226436119

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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